Pfizer to pay $35 million to NC, other states for Rapamune

Drug maker Pfizer will pay $35 million to North Carolina and 41 other states to resolve allegations that it unlawfully promoted the drug Rapamune, Attorney General Roy Cooper announced.

N.C. Department of Justice

Drug maker Pfizer will pay $35 million to North Carolina and 41 other states to resolve allegations that it unlawfully promoted the drug Rapamune, Attorney General Roy Cooper announced.

Cooper and the other attorneys general allege that Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, engaged in unfair and deceptive practices by misrepresenting the uses and benefits of Rapamune, a drug given to patients to help prevent rejection of kidney transplants.

“Promoting a drug to treat a condition without proof that it could help patients is wrong,” Cooper said. “Patients and their doctors deserve honest, accurate information about medications.”

The $35 million recovered through the settlement will be shared among the 42 participating states, including $1.2 million to North Carolina.

Under the settlement announced today, Pfizer will also reform its marketing and promotional practices so that it does not unlawfully promote Rapamune or any Pfizer product. The company may not:

· Make any false, misleading, or deceptive claims regarding any Pfizer Product.

· Make any claim comparing the safety or efficacy of a Pfizer product to another product when that claim is not supported by substantial evidence.

· Promote any Pfizer product for uses not approved by the US Food and Drug Administration (FDA), known as off-label uses.

· Provide incentives to encourage sales for off-label uses of any Pfizer product.

· Seek to have Rapamune included in hospital protocols or standing orders unless it is to be used for an FDA-approved purpose.

· Share information describing any off-label or unapproved use of Rapamune unless such information and materials comply with FDA regulations.

· Seek to influence the prescribing of Rapamune in hospitals or transplant centers in any manner that does not comply with federal law banning kick-backs, including through funding clinical trials.

North Carolina served on the Executive Committee that negotiated the settlement, along with Oregon, Texas, California, Florida, Illinois, Maryland, New York, and Pennsylvania. Also participating in the settlement are Alabama, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee, Utah, Virginia, Washington, and Wisconsin.